FDA (Drugs) recall action 81888
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension because product complaints indicated the reconstituted suspension was observed to be thick.
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to product complaints indicating the reconstituted suspension was observed to be thick.